Cardiac harness delivery device and method

ABSTRACT

The apparatus includes and elongate body having a proximal portion and a distal portion. The body includes a cavity sized to contain a cardiac harness in a compacted configuration and also includes a plurality of elongate push rods movable with respect to the body. The cardiac harness is releasably connected to each of the push rods such that advancement of the push rods in a distal direction moves the harness from a compacted configuration, within the cavity, to an expanded configuration, outside the cavity. The apparatus also includes a releasing member for releasing the connections between the push rods and the harness upon actuation of the releasing member by a user.

RELATED APPLICATIONS

[0001] The present application is related to, and claims priority from,U.S. Provisional Patent Application No. 60/427,079, filed Nov. 15, 2002,the entirety of which is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates generally to a device and methodfor delivering a cardiac harness onto the heart of a patient.

[0004] 2. Description of the Related Art

[0005] Congestive heart failure (“CHF”) is characterized by the failureof the heart to pump blood at sufficient flow rates to meet themetabolic demand of tissues, especially the demand for oxygen. It hasbeen determined that a passive wrap, or cardiac harness, may increasethe efficiency of a heart affected by congestive heart disease. Whileadvances have been made in cardiac harness technology, a satisfactorydevice and method for delivering and positioning the cardiac harnessonto a patient's heart has yet to be provided.

[0006] In one method, access to a patient's heart is achieved through anopen chest procedure, wherein the sternum is split and separated toallow access to the heart. The cardiac harness is then positioned overthe heart by manual manipulation. Such an open chest procedure is highlytraumatic to the patient and, thus, remains a relatively undesirableoption for cardiac harness delivery.

[0007] Present cardiac harness delivery devices do not both adequatelyretain the cardiac harness onto the delivery device and permit theharness to be easily released from the delivery device. For example, onedelivery device utilizes sutures positioned around a circumference ofthe cardiac harness to secure it to the delivery device. Sucharrangements render the cardiac harness difficult to release from thedelivery device, especially on the rearward side of the heart. This isbecause the sutures have to be severed in order to release the cardiacharness from the delivery device. Such an arrangement would not be wellsuited for a minimally invasive procedure because an additionalinstrument would have to be introduced to sever the sutures.Furthermore, attaching the cardiac harness to the delivery device onlyalong a circumference tends to apply a localized load to the cardiacharness, which may cause damage to the device.

SUMMARY OF THE INVENTION

[0008] Accordingly, a need exists for a cardiac harness delivery devicethat overcomes the disadvantages of the prior art. Preferably, thedevice allows release of the cardiac harness from a remote location.Accordingly, a preferred delivery device is configured, in oneorientation, to support the cardiac harness in a compacted configurationto permit minimally invasive delivery of the cardiac harness through arelatively small incision in the patient. Preferably, the deliverydevice includes a plurality of push rods and the cardiac harness issecured to each push rod at at least two spaced apart locations along alongitudinal axis of the push rod. Accordingly, with such anarrangement, the applied load is spread along the length of the cardiacharness, thereby reducing the possibility of damaging the harness duringdelivery.

[0009] In accordance with another embodiment, the present inventioninvolves an apparatus for delivering a cardiac harness, wherein theapparatus includes a support member. The cardiac harness is preloaded onthe support member and attached to the support member by a line. Theline is comprised of a series of interconnected loops, which form areleasable stitch.

[0010] In a further embodiment, the present invention involves anapparatus for delivering a cardiac harness including an elongate bodyhaving a proximal portion and a distal portion. The body has a cavitysized to contain the harness in a compacted configuration. A pluralityof elongate push rods are longitudinally movable with respect to thebody. The cardiac harness is releasably connected to each of the pushrods such that advancement of the push rods in a distal direction movesthe harness from the compacted configuration in the cavity to anexpanded configuration outside the cavity. The apparatus also includes areleasing member which releases the connections between the push rodsand the harness upon actuation of the member by a user.

[0011] Yet another embodiment of the present invention involves anapparatus for delivering a cardiac harness including an elongate bodyhaving a proximal portion and a distal portion. The apparatus alsoincludes a plurality of push rods longitudinally movable with respect tothe body. The cardiac harness is releasably connected to each of pushrods such that movement of the push rods in a distal direction advancesthe harness onto a heart of a patient. The harness is releasable fromthe push rods such that the push rods may be withdrawn from the harnessproximally along a withdrawal path while the harness remains on theheart. The distal portion of the push rods have an inward facing surfacewhich presses against the harness during the withdrawal. The inwardfacing surface is configured such that nonfrictional force componentsparallel to the withdrawal path and attributable to forces exerted bythe inner surface on the harness are directed distally, withoutsubstantial nonfrictional force components being directed proximally.

[0012] Still another embodiment of the present invention involves amethod of delivering a cardiac harness including providing a cardiacharness which is preloaded on a support member. The harness is attachedto the support member by a line forming a releasable stitch. The methodfurther includes positioning the harness so that the harness surrounds aportion of a heart of a patient, and disconnecting the harness from thesupport member by releasing the releasable stitch without cutting theline.

[0013] A further embodiment of the present invention involves anapparatus for creating a passage through the pericardium of a patient topermit access of a cardiac harness delivery device to the heart. Theapparatus includes an introducer sleeve and a dilator sleeve. Theintroducer sleeve has an outer wall defining a proximal end and a distalend. The outer wall has a reduced diameter portion adjacent the distalend. The reduced diameter portion defines a reduced orientation having afirst diameter. The dilator sleeve is sized and shaped to be insertableinto the introducer sleeve to urge the reduced diameter portion into anexpanded orientation having a second diameter, larger than the firstdiameter. The second diameter is of a size sufficient to permit theapparatus to pass therethrough.

[0014] A still further embodiment of the present invention involves anapparatus for assisting the loading of a cardiac harness onto a deliverydevice having a plurality of elongated push rods. The apparatus includesan outer wall defining a generally funnel shaped portion. The funnelshaped portion includes a plurality of channels configured to receivethe plurality of elongated push rods. The outer wall is configured tosupport the push rods in an outwardly splayed orientation.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] These and other features, aspects and advantages of the presentinvention are described with reference to drawings of a preferredembodiment, which are intended to illustrate, but not to limit, thepresent invention. The drawings contain 27 figures.

[0016]FIG. 1 is a perspective view of a cardiac harness delivery deviceconstructed in accordance with certain features, aspects and advantagesof the present invention. The illustrated delivery device comprises abody portion, including an elongate shaft and a housing, and a movableportion, including a control assembly and a plurality of elongate pushrods. A cardiac harness is carried by distal end portions of theplurality of push rods.

[0017]FIG. 2 is an enlarged, partial cutaway view of a distal portion ofthe delivery device of FIG. 1 showing the cardiac harness in a compactedconfiguration within a cavity defined by the housing.

[0018]FIG. 3 is a perspective view of the delivery device of FIG. 1 withthe movable portion in an advanced position relative to the bodyportion.

[0019]FIG. 4 is an enlarged view of a distal portion of the deliverydevice of FIG. 1 indicated by line 4-4 of FIG. 3.

[0020]FIG. 5 is a cross-sectional view of one of the plurality of pushrods taken along line 5-5 of FIG. 4. FIG. 5 illustrates a line, forminga releasable stitch, to secure the cardiac harness to the push rod.

[0021]FIG. 6 is an enlarged, side view of the control assembly of thedelivery device of FIG. 1 indicated by line 6-6 of FIG. 3. Theillustrated control assembly includes a body portion, a cover and arelease member.

[0022]FIG. 7a is a plan view of the body portion of the control assemblyof FIG. 6, taken along line 7-7 of FIG. 6. FIG. 7a illustrates aplurality of channels defined by the body portion of the controlassembly. The channels are configured to receive portions of the lineassociated with each push rod.

[0023]FIG. 7b is an enlarged view of the body portion of the controlassembly of FIG. 7a illustrating the routing of the line portions withinthe channels of the control assembly.

[0024]FIG. 7c is an enlarged view of the arrangement of FIG. 7b, showinga release member being pulled away from a body portion of the controlassembly.

[0025]FIG. 8 is a cross-sectional view of the control assembly of FIGS.6 and 7, taken along line 8-8 of FIG. 7a.

[0026]FIG. 9 is a cross-sectional view of the control assembly of FIGS.6 and 7, taken along line 9-9 of FIG. 7a.

[0027]FIG. 10 is a cross-sectional view of one of the plurality ofelongate push rods, taken along line 10 of FIG. 8.

[0028]FIG. 11a is a cross-sectional view of one of the plurality of pushrods, illustrating the releasable stitch of FIG. 5 being unraveled torelease the cardiac harness from the push rod.

[0029]FIG. 11b is a cross-sectional view of the push rod of FIG. 11a,illustrating the releasable stitch in a further unraveled condition.

[0030]FIG. 11c is a cross-sectional view of the push rod of FIG. 11a,illustrating the releasable stitch in a substantially releasedcondition.

[0031]FIG. 12 is a cross-sectional view of a distal tip of one of theplurality of elongate push rods, taken along line 12-12 of FIG. 4.

[0032]FIG. 13 is a side elevational view of an introducer sleeve portionof an introducer assembly for facilitating introduction of the deliverydevice of FIGS. 1-12 through the pericardium surrounding the heart of apatient.

[0033]FIG. 14 is a side elevational view of the introducer assembly,illustrated in an unassembled condition and including the introducersleeve and a dilator sleeve.

[0034]FIG. 15 is a side elevational view of the introducer assembly inan assembled condition, with the dilator sleeve disposed within theintroducer sleeve.

[0035]FIG. 16 is a perspective view of a heart having a small incisionin the pericardium to permit the delivery device to access the heart.

[0036]FIG. 17 is a perspective view of the heart of FIG. 16 with theintroducer sleeve of the introducer assembly of FIG. 14 positionedwithin the incision in the pericardium.

[0037]FIG. 18 is a perspective view of the heart of FIG. 16 with theintroducer assembly, in an assembled condition, providing an accesspathway through the pericardium for introduction of the delivery device.

[0038]FIG. 19 is a side elevational view of the delivery device of FIGS.1-12, with a pump member, or, specifically, a syringe, attached to asuction assembly of the delivery device. The suction assembly includes asuction cup member, which is configured to securely hold the heartrelative to the delivery device during advancement of the cardiacharness over the heart.

[0039]FIG. 20 is a side elevational view of the delivery device of FIG.19 with the cardiac harness in a partially advanced position.

[0040]FIG. 21 is a side elevational view of the delivery device of FIG.19 with the cardiac harness in a fully advanced position and thereleasing member being actuated to release the cardiac harness from thedelivery device.

[0041]FIG. 22 is a side elevational view of the delivery device of FIG.19 with the cardiac harness being completely released and the pluralityof push rods being retracted.

[0042]FIG. 23 is a side elevational view of the delivery device of FIG.19 with the cardiac harness completely released and illustrating thedelivery device being withdrawn from the heart.

[0043]FIG. 24 is a side elevational view of a loading device, configuredto assist in loading a cardiac harness to the delivery device.

[0044]FIG. 25 is a cross-sectional view of the loading device of FIG.24, taken along the line 25-25 of FIG. 24.

[0045]FIG. 26 is a bottom plan view of the loading device of FIG. 24,taken along the line 26-26 of FIG. 24.

[0046]FIG. 27 is a cross-sectional view of the loading device of FIG. 24illustrating the cardiac harness loaded onto the plurality of push rods.

[0047]FIG. 28a is a cross-sectional view of one of the plurality of pushrods illustrating the formation of an initial loop in the linecomprising the releasable stitch for securing the cardiac harness to thepush rod.

[0048]FIG. 28b is a partial cross-sectional view of the push rod of FIG.28a illustrating the initial formation of a second loop.

[0049]FIG. 28c is a view of the push rod of FIG. 28b illustrating thesecond loop being passed through the initial loop.

[0050]FIG. 29 is a perspective view of another embodiment of a controlassembly.

[0051]FIG. 30 is a perspective view of another embodiment of a push rodadapted to be used with the control assembly of FIG. 29.

[0052]FIG. 31 is an enlarged view of a distal portion of push rod ofFIG. 30 taken along line 31-31.

[0053]FIG. 32 is cross-sectional view of the push rod of FIG. 30 takenalong line 32-32.

[0054]FIG. 33 shows the push rod of FIG. 5, illustrating anotherembodiment and arrangement of a line forming a releasable stitch tosecure a cardiac harness to the push rod.

[0055]FIG. 34 is a plan view of a body portion of the control assemblyof FIG. 29.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0056]FIGS. 1-11 illustrate a preferred embodiment of a cardiac harnessdelivery device, which is generally referred to by the reference numeral30. In a preferred embodiment, the delivery device 30 is configured toreleasably support a cardiac reinforcement device (CRD), such as acardiac harness, and assist in the advancement of the cardiac harnessover the heart of a patient. Once the cardiac harness is positioned onthe heart, the delivery device 30 preferably is configured to releasethe harness and be retractable without causing undesired shifting of thecardiac harness relative to the heart.

[0057] In the illustrated arrangement, the delivery device 30 permitsdelivery of a cardiac harness in a minimally invasive manner. That is,preferably the device 30 permits accurate delivery, positioning, andrelease of the cardiac harness through a relatively small incision in apatient. However, the preferred, or alternative, embodiments of thedelivery device 30 may also be used to deliver a cardiac harness in anopen chest, or other minimally invasive procedure. Further, anembodiment preferably is configured to enable indirect visualization ofat least portions of the device 30 during surgery. For example, portionsof the device may be radiopaque so as to be visualized and guided byfluoroscopy or other methods.

[0058] With specific reference to FIG. 1, the illustrated deliverydevice 30 generally includes a body portion comprised of a handle 32affixed to the proximal end of a hollow, elongate shaft 34. Preferably,a housing 36 is affixed to a distal end of the elongate shaft 34. Theillustrated delivery device 30 also includes a movable portion comprisedof a control assembly 38 and a plurality of elongate push rods 40. Thecontrol assembly 38 and, thus, the push rods 40, are axially slidablealong the shaft 34.

[0059] Preferably, the plurality of push rods 40 extend in a distaldirection from the control assembly 38 and pass through the housing 36.With reference also to FIG. 2, a cardiac harness 42 is releasablysupported on the distal end portions of the elongate push rods 40 in acompacted configuration within the housing 36. Preferably, the cardiacharness 42 comprises an elastic sleeve configured to fit around theheart and to exert a compressive force on the heart. In the illustratedembodiment, the harness 42 comprises several interconnected rows ofundulating elastic members. Preferred cardiac harnesses are described ingreater detail in U.S. patent application Ser. No. 09/634,043, filedAug. 8, 2000; U.S. application Ser. No. 10/242,016, filed Sep. 10, 2002;U.S. application Ser. No. 10/287,723, filed Oct. 31, 2002; and U.S.Application No. 60/409,113, filed Sep. 5, 2002, the entirety of each ofwhich are incorporated by reference herein. It is to be understood thataspects of the delivery device 30 discussed herein can be used inconnection with several other types of cardiac harnesses.

[0060] The term “cardiac harness” as used herein is a broad term thatrefers to a device fit onto a patient's heart to apply a compressiveforce on the heart during at least a portion of the cardiac cycle. Adevice that is intended to be fit onto and reinforce a heart and whichmay be referred to in the art as a “girdle,” “sock,” “jacket,” “CRD,” orthe like is included within the meaning of “cardiac harness.”

[0061] The control assembly 38 and plurality of push rods 40 are movableaxially with respect to the shaft 34 from the retracted positionillustrated in FIG. 1 to an advanced, or deployed position, asillustrated in FIGS. 3 and 4. Thus, the delivery device 30 is configuredto deploy the cardiac harness 42 from a compacted configuration withinthe housing 36 to an expanded position outside of the housing 36 therebydelivering the cardiac harness 42 onto a heart 43 (FIGS. 3 and 4), as isdescribed in greater detail below.

[0062] The handle 32 is fixed to the shaft 34 in the illustratedembodiment. However, it is to be understood that in other arrangementsthe handle 32 may be movable relative to the shaft 34 along with thecontrol assembly 38. Additionally, another embodiment may not employ ahandle 32. Further, with reference to FIG. 1, a stop 39 preferably isprovided on the shaft 34. The stop 39 comprises a raised portion thatengages the control assembly 38 so that the assembly 38 cannot movedistally over the shaft 34 beyond the stop 39. As such, the harness 42is not advanced too far over the heart 43.

[0063] With reference again to FIG. 2, the housing 36 preferably is arelatively thin-walled, tubular member. Desirably, the housing 36 issupported substantially concentric with the shaft 34 to define aninterior cavity 44 between an inner surface of the housing 36 and anouter surface of the shaft 34. Preferably, the cavity 44 is sized andshaped to contain the cardiac harness 42 in a compacted configurationtherein.

[0064] As indicated above, preferably the device 30 is configured todeliver the cardiac harness 42 in a minimally invasive procedure.Accordingly, a preferred housing 36 has a nominal outer diameter of lessthan about 2 inches and, more preferably, less than about 1.5 inches.However, in additional, non-minimally invasive embodiments, the housing36, if provided, may be larger than the values given above. In sucharrangements, the harness 42 may be supported by the device 30 in aconfiguration substantially similar to the configuration of the harness42 when positioned on a heart. That is, the cardiac harness does nothave to be supported in a “compacted” configuration by the device, butmay be supported in a configuration closer to its relaxed size andshape.

[0065] In the embodiment shown in FIGS. 1-3, the housing 36 is generallycylindrical. It is to be understood that, in another preferredembodiment, the housing is elliptical. As such, the housing may have amajor axis and minor axis. This configuration may be especiallybeneficial for advancing the housing through body passages havingrelatively narrow clearance, such as advancing the housing between ribs.

[0066] With continued reference to FIG. 2, a base portion 46 of thehousing 36 preferably defines a closed end of the cavity 44 and supportsthe housing 36 relative to the shaft 34. The base end 46 may be securedto the shaft 34 by mechanical fasteners, adhesives or other suitablemethods apparent to one of skill in the art. In one embodiment, the baseend 46 is rotatable relative to the shaft 34. Preferably, the distal endof the housing is open to define an open, distal end of the cavity 44 topermit the cardiac harness 42 to be advanced from the cavity 44.

[0067] Preferably, an outer wall 48 of the housing 36 defines aplurality of channels 50 (FIG. 4) extending axially throughout thelength of the housing 36. Each of the channels 50 preferably is sizedand shaped to slidably receive one of the plurality of push rods 40.Thus, preferably, the number of channels 50 is equal to the number ofpush rods 40. Further, each channel 50 preferably opens into a cavity 44along at least a portion of the length of the channel 50.

[0068] In the illustrated embodiment, six push rods 40 and channels 50are provided and are substantially equally spaced around thecircumference of the housing 36. In an additional arrangement, however,the channels 50 may be omitted and the push rods 40 may simply berestrained from moving radially outwardly by the sidewall 48 of thehousing 36. Other suitable arrangements to guide the push rods 40 andhouse the cardiac harness 42 may also be used.

[0069] With continued reference to FIGS. 1-4, the delivery device 30preferably includes a positioning arrangement configured to hold thedelivery device 30 in a desired position relative to the heart 43. Inthe illustrated arrangement, the positioning arrangement comprises asuction cup member 52 supported on a distal end of the shaft 34. A tube54 extends through the shaft 34 and is connected to the suction cupmember 52. A distal end of the tube 54 opens into an interior spacedefined by the suction cup member 52. The proximal end of the tube 54includes a connector 58 that allows connection of the tube 54 to a pumpmember such as a syringe or other source of vacuum. Accordingly, oncethe delivery device is properly positioned, air may be withdrawn fromwithin the tube 54 to create a vacuum condition within the interiorspace of the suction cup member 52, thereby permitting the suction cupmember 52 to securely hold the heart of a patient.

[0070] A clip 56 secures the tube 54 relative to the handle 32 toprevent the proximal end of the tube 54 from passing through the shaft34. Thus, the clip 56 also operates to secure the suction cup member 52to the delivery device 30. In a preferred embodiment, the tube 54 andsuction cup member 52 are not rigidly affixed to the shaft 34 so thatthe shaft 34 may be moved relative to the tube 54 and suction cup 52. Inanother embodiment, the shaft 34 and a proximal end of the suction cup52 are threaded so that the suction cup may be threaded onto the shaft.In still other embodiments, other structure may be used to releasablyconnect the suction cup to the shaft.

[0071] With reference next to FIG. 5, preferably the cardiac harness 42is secured to a distal end portion of each of the plurality of push rods40 by a line, generally referred to by the reference numeral 60, that isconfigured into a releasable stitch. As shown in FIG. 5, a line 60 a isassociated with one of the plurality of push rods 40 and is arrangedinto a releasable stitch configured to secure the cardiac harness 42 tothe push rod 40. Although not individually illustrated, preferably, eachof a plurality of such lines 60 b-f secure the cardiac harness 42 to acorresponding one of the remainder of push rods 40 in a manner similarto line 60 a, which is illustrated in FIG. 5. Desirably, the line 60 ais arranged into a series of interconnected loops that are releasable byactuation of the control assembly 38 in a manner described in greaterdetail below. Release of the interconnected loops, in turn, releases thecardiac harness 42 from the push rod 40.

[0072] The illustrated push rod 40 includes a plurality of throughholes,or openings 62, 64 a-i, extending from an outward facing surface 40 a ofthe push rod 40 to an inward facing surface 40 b of the push rod 40. Inthe illustrated embodiment, ten openings 62, 64 a-i are provided,however, other numbers of openings may be provided to permit other typesand sizes of cardiac harnesses to be secured to the delivery device 30.Desirably, the openings 64 a-i are equally spaced from one another, withthe space between the distal most opening 62 and the opening 64 a beingless than the equal spacing between openings 64 a-i. Preferably, thespace between the openings 62 and 64 a is sufficient to accommodate thediameter of an individual wire, which forms an uppermost row 66 a of theillustrated cardiac harness 42. In addition, preferably the remainder ofthe openings 64 a-i are spaced from one another a distance substantiallyequal to a height of one row 66 b-h of the cardiac harness. Such anarrangement permits positioning of the wire of a single row 66 b-h ofthe cardiac harness 42 between each pair of openings 64 a-i.

[0073] Although the line 60 a is shown as being spaced from both theoutward facing surface 40 a and inward facing surface 40 b in FIG. 5,preferably, the line 60 a is pulled tight after passing through theopenings 62, 64 a-i to secure the cardiac harness 42 directly againstthe inward facing surface 40 b of the push rod 40. The spacedorientation of the line 60 a depicted in FIG. 5 is merely for thepurpose of clearly illustrating the configuration of the releasablestitch.

[0074] In a preferred embodiment of the releasable stitch, a first endof the line 60 a is arranged into a slip knot 80, which defines a firstloop 82 a positioned on the outward facing surface 40 a side of the pushrod 40. The slip knot 80 desirably is created near one end of the line60 a such that, along with the first loop 82 a, a short end portion 83of the line 60 a is created. The remainder of the line 60 a is arrangedinto interconnecting loops to create the releasable stitch, as isdescribed below.

[0075] The line 60 a passes through the distal most opening 62 to theinward facing surface 40 b side of the push rod 40. Preferably, the line60 a then passes around the wire of the uppermost row 66 a of thecardiac harness 42 before passing through the opening 64 a back to theoutward facing surface 40 a side of the push rod 40. Thus, between theopenings 62 and 64 a, the line 60 a creates a securing portion 84 a thatholds the row 66 a of the cardiac harness 42 against the inward facingsurface 40 b of the push rod 40.

[0076] Once on the outward facing surface 40 a side of the push rod 40,the line 60 a passes through the first loop 82 a and is arranged to forma second loop 82 b. Preferably, the second loop 82 b is large enough sothat it extends toward the proximal end of the push rod 40 a sufficientdistance to pass beyond the next adjacent opening 64 b. The line 60 athen passes back through the first loop 82 a and the opening 64 a to theinward facing surface 40 b side of the push rod 40. The line 60 acreates another securing portion 84 b, which secures a wire of a secondrow 66 b of the cardiac harness 42 to the push rod 40.

[0077] Preferably, in a similar manner, interconnected loops 82 cthrough 82 h are formed. Each of the loops 82 c-h are positioned on theoutward facing surface 40 a side of the push rod 40 and correspond withrespective securing portions 84 c-84 h, which secure a respective wireof each row 66 c-h of the cardiac harness 42 against an inward facingsurface 40 b of the push rod 40. Although, preferably, each securingportion 84 a-h of the line 60 a secures a single row 66 a-h of thecardiac harness 42 to the push rod 40, in other configurations more orless than one row of the harness 42 may be secured by a single securingportion 84 a-h. Further, although in the illustrated embodiment, onehole 64 of the push rod 40 generally corresponds to one row 66 of theassociated harness 42, it is to be understood that, in otherembodiments, one row 66 may correspond with more or less than one hole64 and more or less than one securing portion 84.

[0078] In accordance with this arrangement, the cardiac harness 42 issecured to each push rod 40 at at least two longitudinally-spacedlocations. In the illustrated embodiment, the harness 42 is secured toeach push rod 40 at eight longitudinally-spaced locations, or each ofthe eight rows 66 a-h of the cardiac harness 42 is secured to each ofthe push rods 40.

[0079] Preferably, a proximal-most, or retaining, loop 86 a is arrangedto inhibit the remaining loops 82 a-h from unraveling prematurely. In apreferred arrangement, the retaining loop 86 a passes through the nextdistal loop 82 h in a manner similar to the arrangement of loops 82 a-has described above. The retaining loop 86 a, however, has a sufficientlength to extend in a proximal direction along the push rod 40 to thecontrol assembly 38. Preferably, the loop 86 a passes through thelowermost opening 64 i to the inward facing surface 40 b side of thepush rod 40 and is extended along the push rod 40 in a proximaldirection. Within the control assembly 38, the loop 86 a is loopedaround a retaining rod 68 (shown schematically in FIG. 5).

[0080] The remaining end portion 100 a of the line 60 a, after formingthe retaining loop 86 a, is passed through the loop 82 h and the opening64 h to the inward facing surface 40 b side of the push rod 40. The endportion 100 a of the line 60 a also extends in a proximal directionalong the push rod 40 and is tied off on the retaining rod 68. Thus, inthe illustrated arrangement, unravelment of the releasable stitch isprevented by the combination of the retaining loop 86 a being loopedaround the retaining rod 68, and the end portion 100 of the line 60 abeing tied onto, the retaining rod 68. Although shown tied onto theretaining rod 68, desirably, the end portion 100 is tied off onto areleasable portion of the control assembly 38, rather than the retainingrod 68 itself, as will be described in greater detail below.

[0081] In an alternative arrangement, the retaining loop 86 a may not belooped around the retaining rod 68, but may be inhibited from unravelingby an alternatively suitable arrangement. For example, it iscontemplated that the retaining loop 86 a may be formed approximatelythe same size as the remainder of the interconnected loops 82 a-h andmay be tucked between the adjacent loop 82 h and the outward facingsurface 40 a of the push rod 40. Thus, the retaining loop 86 a isinhibited from unraveling by a frictional force of the adjacent loop 82h holding the retaining loop 86 a against the outward facing surface 40a. When a sufficient pulling force is applied to the end portion 100,the retaining loop 86 a overcomes the frictional force of the loop 82 hand the outward facing surface 40 a and is drawn through the opening 64h, thus permitting unraveling of the releasable stitch.

[0082] With reference next to FIGS. 6-9, a preferred embodiment of thecontrol assembly 38 is described in greater detail. As indicated above,the control assembly 38 is movable axially relative to the shaft 34 ofthe delivery device 30. Preferably, the control assembly 38 includes aposition-retaining arrangement, such as a friction brake assembly 102,for example. The friction brake assembly 102 is configured to permit thecontrol assembly 38 to be selectively retained in a desired positionrelative to the shaft 34. Preferably, the friction brake assembly 102 isconfigured to be easily actuatable, along with movement of the controlassembly 38, by one hand of a user of the device 30.

[0083] With particular reference to FIGS. 6 and 9, the illustratedfriction brake assembly 102 includes a brake element 104 and a biasingmember, such as a spring 106. The brake element 104 includes an annularcentral portion 104 a surrounding the shaft 34. Opposing end portions104 b, 104 c extend in an outward direction from the central portion 104a substantially opposite from one another. The first end portion 104 bis retained within a channel 108 of the control assembly 38, preferablyby a pin 110. The pin 110 is supported within cavities (not shown) ofthe control assembly 38 on each side of the channel 108. Thus, the brakeelement 104 is pivotable generally about an outer surface of the pin110.

[0084] The spring 106 is retained within a cavity 111 and is arranged tobias the second end 104 c of the brake element 104 away from the controlassembly 38. Preferably, the spring 106 biases the brake element 104such that an inner diameter-defining surface of the central portion 104a is in frictional contact with the shaft 34 so as to secure the controlassembly 38 in a desired position relative to the shaft 34. The brakeelement 104 may be pivoted toward the control assembly 38 by pushing theend 104 c toward the control assembly 38 to disengage the brake element104 from the shaft 34 and permit relative movement between the controlassembly 38 and the shaft 34. In another embodiment, two such brakeelements 104 are provided. However, each brake element is oriented topivot in an opposite direction. As such, one brake element betterprevents distal movement of the assembly relative to the shaft, and theother brake element better prevents proximal movement of the assemblyrelative to the shaft.

[0085] With particular reference to FIGS. 6 and 8, the control assembly38 preferably includes a substantially cylindrical body portion 112. Aplurality of passages, generally referred to by the reference numeral114, extend axially through the body portion 112 of the control assembly38. In the illustrated embodiment, the passages 114 are substantiallycylindrical in shape and are equally distributed in a circulararrangement coaxial with the shaft 34. Preferably, the passages 114 aregenerally aligned with corresponding channels 50 formed in the housing36.

[0086] A cover 116 is fixed to a proximal end of the body portion 112.The cover 116 closes a proximal end of the passages 114 and the cavity111. A plurality of fasteners, such as screws 118, engage correspondingthreaded apertures 120 (FIG. 7a) of the body portion 112 to secure thecover 116 to the body portion 112.

[0087] With reference also to FIG. 7a, in a preferred embodiment, thebody portion 112 includes six passages 114, referred to specifically bythe reference numerals 114 a-114 f. As a matter of convenience, thepassages 114 a-114 f are referred to herein by their relative positionsas depicted in FIGS. 7a-c. As such, passages 114 a and 114 f comprise anupper pair of passages, passages 114 b and 114 e comprise a central pairof passages and passages 114 c and 114 d comprise a lower pair ofpassages. Passage 114 a is positioned to the right of a vertical axisA_(V) passing through the center of the shaft 34 in FIGS. 7a and 7 b.The remaining passages 114 b-114 f are distributed in a clockwisedirection in an equally spaced relation to one another.

[0088] With particular reference to FIGS. 7a and 8, each of theabove-described passages 114 a-f are configured to receive a proximalend of one of the push rods 40. The push rods 40 are secured withintheir respective passages 114 a-f by a shaft 150 passing through anopening (not shown) within the push rod 40 and being supported by thebody portion 112 of the control assembly 38. Thus, as described above,the push rods 40 are fixed for axial movement with the control assembly38.

[0089] In the illustrated embodiment, the push rods are supportedgenerally in the center of the passages 114 a-f, with their respectiveinner surfaces 40 a arranged generally tangentially to the center axisof the shaft 34. In addition, with reference also to FIG. 10, a centerportion 40 c of each push rod 40 is generally semicircular incross-section such that the inward facing surface 40 a defines a recess152. Preferably, the recess 152 is configured to accommodate one of thelines 60 a-f, respectively, as described above in relation to FIG. 5. Asshown in FIG. 10, the line 60 a consists of the retaining loop 86 a andthe free end 100 a, as is also described above in relation to FIG. 5.

[0090] With reference next to FIGS. 7a-c, a plurality of channels,referred to generally by the reference numeral 122, are defined by aproximal end surface of the body portion 112 of the control assembly 38.Each of the channels 122 interconnect two of the passages 114 a-114 fand are configured to accommodate a portion of one or more lines, suchas the line 60 a, as is described in greater detail below. Specifically,in a preferred arrangement, a first channel 122 a extends generallyparallel to the vertical axis A_(V) and interconnects the passages 114 aand 114 c. Similarly, a second channel 122 b extends generally parallelto the channel 122 a and interconnects the passages 114 d and 114 fThird and fourth channels 122 c, 122 d interconnect the passages 114 aand 114 b and passages 114 b and 114 c, respectively. Similarly, fifthand sixth channels 122 e, 122 f interconnect passages 114 f and 114 eand passages 114 e and 114 d, respectively.

[0091] Preferably, each of the channels 122 a-f are arranged togenerally intersect a center of the passages 114 that they interconnect.The channels 122 a, 122 c and 122 d form a triangular shape on theright-hand side of the vertical axis A_(V). The channels 122 b, 122 eand 122 f form a triangular shape on the left-hand side of the verticalaxis A_(V), which shape is a mirror image of the triangular shapedefined by channels 122 a, 122 c and 122 d.

[0092] An additional channel 134 interconnects the passages 114 a and114 f and extends in a direction generally parallel to a horizontal axisA_(H) as depicted in FIGS. 7a-c. The channel 134 is defined by aproximal surface of the body portion 112 and, preferably, issubstantially larger in both width and depth than the channels 122 a-f.Preferably, the channel 134 has a width approximately one-half thediameter of the passages 114 a, 114 f and is semicircular incross-sectional shape. Desirably, the channel 134 passes approximatelythrough the centers of the passages 114 a, 114 f.

[0093] The control assembly 38 also includes a release member 136 thatpreferably is configured to selectively release the releasable stitch,thereby releasing the cardiac harness 42 from the delivery device 30.With reference also to FIG. 9, a portion of the release member 136preferably is received within a cavity 137 of the body portion 112,which is located on an opposite side of the horizontal axis A_(H) fromthe channel 134. The cavity 137 defines a support surface 138 which,along with a corresponding portion of the distal surface of the cover116 (see FIG. 6), supports a portion of the release member 136.

[0094] Desirably, the retaining rod 68, illustrated schematically inFIG. 5, comprises a pair of rods 68 a,b that are part of the releasemember 136 as shown in FIGS. 7a-c and 9. The pair of rods 68 a,b extendoutwardly (depicted vertically in FIGS. 7a-c) from the release member136 and are slidably received in corresponding bores 139 formed withinthe body portion 112 of the control assembly 38. Preferably, the bores139 are spaced on opposing sides of the vertical axis A_(V). The rods 68a,b preferably are long enough such that distal end portions of the rods68 a,b pass through the channel 134.

[0095] The release member 136 defines a pull portion 140, which extendsin an outward direction away from the body portion 112. The pull portion140 preferably is generally annular in shape, such that a user of thedelivery device 30 can grasp the release member 136 with one or morefingers extending through a hole defined by the pull 140. It is to beunderstood that other suitable constructions may also be used to permita user of the device 30 to grasp and pull the release member 136 awayfrom the body portion 112, such as providing a pull tab, for example.

[0096] The release member 136 also includes a preferably trapezoidalshaped cavity 142 extending inwardly from an inward facing surface 144of the release member 136. The cavity 142 preferably is sized and shapedto avoid closing off the passages 114 c and 114 d.

[0097] The release member 136 preferably includes an attachment portion146 that extends from a wall of the cavity 142 and toward the bodyportion 112. Preferably, the attachment portion 146 is arranged so that,as shown on FIGS. 7b and 9, a space 147 is disposed between theattachment portion 146 and the support surface 138 of the body portion112. As shown more particularly in FIG. 9, the attachment portion 146preferably is not as thick as the release member 136 and, desirably isabout ¼ or less of the thickness of the release member 136. As shownparticularly in FIG. 9, an upper surface 149 of the attachment portion146 preferably is spaced 147 from the support surface 138 of the bodyportion 112.

[0098] With reference again to FIGS. 7a-c and 8, the attachment portion146 preferably includes a plurality of holes 148 extending therethroughin a direction generally parallel to a longitudinal axis of the shaft34. In the illustrated embodiment, there are six holes 148, one hole 148corresponding to each of the passages 114 a-f.

[0099] With particular reference to FIG. 7b, the free ends 100 of thelines 60 preferably are tied to corresponding holes 148 of theattachment portion 146. As a more specific example, free end 100 a ofline 60 a extends downwardly along the corresponding rod 40 (see FIG.10) and enters passage 114 a, from which it is directed into channel 122a and into the cavity 142. The free end 100 a is then tied onto one ofthe holes 148 of the attachment portion 146. Thus, the free end 100 a ofthe line 60 a is affixed to the release member 136.

[0100] The retention loop 86 a portion of line 60 a also extendsdownwardly along the corresponding rod 40 (see FIG. 10) and into thepassage 114 a. From the passage 114 a the loop 86 a is directed into thechannel 134 and, as illustrated in FIG. 7b, is looped about theright-most rod 68 a of the release member 136. Looping the retentionloop 86 a around the rod 68 a anchors the loop 86 a and thus preventsthe line 60 a from unraveling. Note that for convenience inillustration, the retention loop 86 a, which actually comprises twoportions of line as shown in FIG. 10, is illustrated in FIG. 7b as asingle line. This is done to present a less-cluttered drawing.

[0101] The other free ends 100 b-f and retention loops 86 b-f preferablyare arranged similarly, although they are customized for theirrespective positions in the device. For example, free end 100 b extendsfrom passage 114 b through channel 122 d into the cavity 142 and isaffixed to a hole 148. Free end 100 c is directed directly from passage114 c into the cavity 142 and is affixed to a hole 148. Free end 100 dalso extends directly from the passage 114 b into the cavity 142 and isaffixed to a hole 148. Free end 100 e extends out of passage 114 ethrough channel 122 f into the cavity 142 and is affixed to a hole 148.Free end 100 f extends from passage 114 f and through channel 122 b intothe cavity 142 and is affixed to a hole 148.

[0102] With regard to the retention loops 86, retention loop 86 bextends from passage 114 b through channel 122 c into channel 134 and islooped around the right rod 68 a. Loop 86 c extends from passage 114 cthrough channel 122 a into channel 134 and is looped about the right rod68 a. Retention loop 86 d extends from passage 114 d through channel 122b into channel 134 and is looped about the left rod 68 b. Retention loop86 e extends out of passage 114 e through channel 122 e into channel 134and is looped about the left rod 68 b. Retention loop 86 f extends frompassage 114 f into channel 134 and is looped about the left rod 68 b.

[0103] In operation, the release member 136 is configured to releaseloops 86 a-f, unravel the lines 60 a-f from the push rods 40 and therebyrelease the cardiac harness 42 from the push rods 40. More specifically,and with reference to FIG. 7c, as the release member 136 is pulled awayfrom the body 112 of the control assembly 38, the rods 68 a-b are alsopulled through the channel 134 such that the retention loops 86 a-f arereleased from the rods 68 a-b. Simultaneously, because the free ends 100a-f of the lines 60 a are tied onto one of the holes 148 of theattachment portion 146, the release member 136 pulls on the free ends100 a-f. Since the retention loops 86 a-f are released from the rods 68a-b, pulling of the free ends 100 a-f unravels the lines 60 a-f, therebyreleasing the cardiac harness 42 from the push rods 40, as is describedfurther below in connection with FIGS. 11a-c.

[0104]FIGS. 11a through 11 c illustrate a preferred sequence ofunravelment of the releasable stitch of line 60 a. With additionalreference to FIG. 5, as described above, in a secured position of thereleasable stitch, preferably the retaining loop 86 a is looped aroundthe rod 68 of the release member 136 to inhibit unravelment of thestitch. However, when the rod 68 is retracted to release the retainingloop 86 a, and the free end 100 a is pulled by the release member 136,the retaining loop 86 a is pulled through the loop 82 h by the free end100 a.

[0105] Returning to FIG. 11a, as the release member 136 continues to bepulled away from the main body 112 of the control assembly 38, the loop82 h is pulled through the loop 82 g in a manner similar to thatdescribed above. With reference to FIG. 11b, as the free end 100 acontinues to be pulled, each successive loop 82 g, 82 f, 82 e, 82 d, 82c, 82 b, 82 a is pulled through its distally-adjacent loop. In FIG. 11b,loop 82 e is illustrated as being pulled through loop 82 d.Subsequently, loop 82 d is pulled through loop 82 c, which is thenpulled through loop 82 b. Finally, loop 82 b is finally pulled throughthe initial loop 82 a, as illustrated in FIG. 12c.

[0106] The initial loop 82 a, which preferably comprises a slip knot 80,preferably completely unties itself and is pulled through thedistal-most opening 62 to release the cardiac harness 42 from the pushrod 40. In a similar manner, because the remainder of the lines 60 b-fare also secured to the release member 136, the cardiac harness 42preferably is simultaneously released from each of the plurality of pushrods 40.

[0107] With next reference to FIG. 12, a distal end of one of theplurality of push rods 40 is shown in section. As described above, thepush rod 40 has an inward facing surface 40 b, which faces a center axisof shaft 34, and an outward facing surface 40 a, which faces away from acenter axis of the shaft 34. Thus, in operation, the inner surface 40 bof each of the push rods 40 is positioned adjacent to, and preferably incontact with, the cardiac harness 42.

[0108] The distal end of the push rod 40 includes a tip portion 154that, in a preferred arrangement, is canted outwardly away from a centeraxis of the shaft 34. Thus, the inner surface 40 b of the tip portion154 defines an angle θ with respect to a line 156 extending from theinner surface 40 b of the remainder of the push rod 40. In a preferredarrangement, the angle θ is between about 5-60 degrees, and morepreferably is between about 10-45 degrees. Most preferably, the angle isbetween about 15-35 degrees.

[0109] As will be appreciated by one of skill in the art, althoughpreferably the inner surface 40 b is generally planar in a relaxedorientation, the push rod 40 is configured to be deflectable so as tosplay outwardly from a distal end of the housing 36 so as to conform toan outer surface of a patient's heart while in use. Accordingly, thepush rod 40 is not always oriented such that the inner surface 40 b isnecessarily planar. However, when the push rod 40 is in a splayedorientation, any given point on the surface 40 b preferably is eitherthe same perpendicular distance from a center axis of the shaft 34, or agreater distance, than any point on the surface 40 b proximal to thegiven point. That is, preferably, the inward facing surface 40 b doesnot have any inwardly extending portions when moving from a proximal endof the push rod 40 toward a distal end of the push rod 40.

[0110] In operation, once the cardiac harness 42 has been positioned ona patient's heart, the control assembly 38 is retracted relative to theshaft 34 such that the plurality of push rods 40 are also retractedrelative to the cardiac harness 42. Upon retraction of the deliverydevice 30, relative motion is experienced between the inner surface 40 band the cardiac harness 42. That is, the inner surface 40 b of the pushrod 40 slides along the cardiac harness 42 along a withdrawal path in awithdrawal direction WD, as indicated by the arrow in FIG. 12.

[0111] Preferably, the tip 154 is configured with an angle such thatupon sliding motion of the push rod 40 relative to the cardiac harness42, no force is exerted by the inner surface 40 b tending to drag thecardiac harness 42 from its position on the heart. That is, theconstruction of the inward facing surface 40 b of the push rods 40 issuch that non-frictional force components parallel to the withdrawalpath and attributable to forces exerted by the inner surface 40 b on thecardiac harness 42 are directed distally, without substantialnon-frictional force components directed proximally, or in thewithdrawal direction WD. Advantageously, once the cardiac harness 42 isproperly positioned on the heart, retraction of the push rods 40 doesnot disturb the positioning of the harness 42.

[0112] With next reference to FIGS. 13-17, an introducer assembly 160assists in creating an access opening in the pericardium of a patient'sheart to permit access of the delivery device 30 to the heart. In theillustrated embodiment, the introducer assembly 160 includes anintroducer sleeve 162 and a dilator sleeve 164.

[0113] With particular reference to FIG. 13, the introducer sleeve 162preferably is a thin-walled, tubular element having a substantiallycircular cross-sectional shape. A distal end 163 of the sleeve 162comprises a plurality of flared portions 165 that are biased outwardlyfrom a longitudinal axis As of the sleeve 162. In the illustratedembodiment, a portion of the sleeve 162 is divided into several elongatestrips 166. Preferably, the elongate strips 166 are spaced apart fromeach other. In a preferred arrangement, about the distal-most ⅔ of thelength of the introducer sleeve 162 is divided into the spaced apartelongate strips 166. Preferably, six such strips 166 are provided.However, other suitable numbers of strips may also be used.

[0114] With continued reference to FIG. 13, the strips 166 preferablyextend generally parallel to the longitudinal axis A_(S) of the sleeve,except that at the distal end of each strip, a flared portion 165 isbiased generally outwardly. Preferably, the strip 166 bends at atransition portion 167 to transition from the generally straight portionof the strip to the flared portions 165. In the illustrated embodiment,the flared portions 165 also extend somewhat in a direction generallytransverse to the longitudinal axis A_(S).

[0115] Preferably, a resilient annular member, such as an elastic ring168, is positioned toward the distal end 163 of the introducer sleeve162 at or adjacent the transition portions 167 of the elongate strips166. Desirably, the elastic ring 168 is configured to bias the strips166 into a reduced-diameter portion, which is operable to ease insertionof the introducer sleeve 162 into an incision in the pericardium, as isdescribed in greater detail below.

[0116] With particular reference to FIG. 14, the dilator sleeve 164preferably is a thin-walled, tubular member, which is also substantiallycircular in cross-section. An outer diameter of the dilator sleeve 164is configured to be slightly smaller than an inner diameter of theintroducer sleeve 162. Accordingly, the dilator sleeve 164 may beslidably inserted within the introducer sleeve 162, as illustrated inFIG. 15. The dilator sleeve 164 may also have an enlarged diameterportion 170 on its proximal most end to limit the insertion within theintroducer sleeve 162. Further, a releasable locking system may beprovided so that the dilator sleeve 164 may be releasably engaged withthe introducer sleeve 162.

[0117] In the assembled condition illustrated in FIG. 15, the dilatorsleeve 164 presses against an inner surface of the reduced-diameterportion of the introducer sleeve 162 to force the reduced-diameterportion outward against the biasing force provided by the elastic ring168. Thus, in the assembled configuration, the reduced diameter portionof the introducer sleeve 162 is enlarged and the introducer assembly 160is configured to provide an access pathway for the delivery device 30.Preferably, an inner diameter of the sleeve 164 is greater than an outerdiameter of the delivery device 30 so that the device can be advancedthrough the sleeve 164.

[0118]FIG. 16 illustrates a human heart 172, which is enclosed within apericardium 174. To permit introduction of the delivery device 30 towithin the pericardium 174, preferably, a small incision 176 is made inthe pericardium 174 adjacent the apex of the heart. With reference nextto FIG. 17, the introducer sleeve 162, in its contracted orientation, isintroduced into and through the incision 176. In practice, one side ofthe distal end of the introducer sleeve 162 may be inserted into theincision 176 first, followed by the remaining side.

[0119] With reference next to FIG. 18, once the flared portions 165 ofthe introducer sleeve 162 have been advanced through the slit 176, thedilator sleeve 164 is then introduced within the introducer sleeve 162to urge the introducer sleeve 162 into its expanded configuration. Inthis configuration, the flared portions 165 are expanded to a diametergreater than the diameter of the rest of the introducer sleeve 162 andpreferably greater than the size of the incision 176. As such, theflared portions 165 press upon and open the incision 176 and thesurrounding portion of the pericardium so as to create a space betweenat least part of the pericardium and the heart. Further, the flaredportions 165 function as a lock to resist pulling the introducer out ofthe incision 176. Accordingly, the introducer assembly 160 iseffectively locked in place between the heart 172 and the pericardium174.

[0120] Since the dilator sleeve 164 dilates the introducer sleeve 162,an access pathway is created to allow the delivery device 30 to beadvanced therethrough and through the pericardium. The delivery device30 is advanced through the pathway so as to deliver the cardiac harness42 onto the heart 172. When the procedure is completed, the deliverydevice 30 is retracted through the access pathway and the introducerarrangement 160 is removed in generally the reverse order of theinsertion.

[0121] As discussed above, in an additional embodiment the housing 36 isgenerally elliptical. It is to be understood that, in still furtherembodiments, the introducer sleeve 162 and dilator sleeve 164 are alsoelliptical, having a major axis and a minor axis. Further, each of thesecomponents may have any desired cross-sectional shape. As such, they mayhave a shape that is customized for any desired type or shape ofminimally invasive surgical entry path.

[0122]FIGS. 19-23 illustrate the use of a delivery device 30, preferablyconfigured substantially as described above, to deliver a cardiacharness 42 onto a heart 172. Preferably, the delivery device 30 isconfigured to locate and grasp the heart 172, accurately position thecardiac harness 42 onto the heart 172, and permit withdrawal of thedelivery device 30 without disturbing the positioning of the cardiacharness 42.

[0123] With reference to FIG. 19, preferably, the suction cup 52 of thedelivery device 30 engages an apex portion 180 of the heart 172, whichis illustrated schematically in FIGS. 19-23. The distal end of thedelivery device 30 may access the heart 172 through any suitable method,but preferably through a minimally invasive procedure such as thatdescribed in relation to FIGS. 16-18. In FIGS. 19-23, the pericardium174 (FIG. 16) is omitted to ease illustration.

[0124] A pump device, such as a syringe 182, is connected to the hose 54through the connector 58. Desirably, the syringe 182 is connected to thehose 54 with the plunger 184 in a compressed position. Once connected,the plunger 184 is retracted (as indicated by the arrow 185 in FIG. 19)to create a vacuum condition within the hose 54 and, thus, within thespace defined by the interior of the suction cup member 52. Due to thevacuum condition, the suction cup member 52 grasps the apex 180 suchthat the heart 172 is held in a desired position relative to thedelivery device 30.

[0125] Preferably, the connector 58 includes a one-way valve 59 that isconfigured to inhibit air from flowing from the syringe to the tube 54through the connector 58. Accordingly, the syringe 182 may be removedfrom the tube 54 once a vacuum condition has been created. Although asyringe 182 is preferred as a pump member due to its simplicity and lowcost, other suitable pump devices may also be used to create a vacuumwithin the tube 54, as will be appreciated by one of skill in the art.

[0126] With reference next to FIG. 20, once the delivery device 30 hasbeen properly secured to the base 180 of the heart 172, the controlassembly 38 may be advanced, relative to the shaft 34, toward the heart172, as indicated by the arrow 186 in FIG. 20. The plurality of pushrods 40 are advanced toward the heart 172 with the control assembly 38thereby advancing the cardiac harness 42 from its compactedconfiguration within the housing 36 onto the heart 172 in a directionfrom the base 188 to the apex 180, as indicated by the arrow 190 in FIG.20. As shown, the harness 42 preferably stretches elastically to fitover the heart. However, it is to be understood that a substantiallynon-elastic harness embodiment can also be delivered by this device andmethod.

[0127] As illustrated in FIG. 20, the plurality of push rods 40 splayoutwardly to conform to the shape of the heart 172 as they are advancedrelative to the shaft 34 of the delivery device 30. As described above,preferably the tips 154 of the push rods 40 are canted at an outwardangle θ relative to the remainder of the push rod 40 such that contactof the tip 154 with the heart 172 is generally avoided, therebypreventing trauma to the heart 172.

[0128] With reference to FIG. 21, the control assembly 38 continues tobe advanced until the cardiac harness 42 is properly positioned on theheart 172. Once the cardiac harness 42 is properly positioned, therelease member 136 is pulled away from the main body 112 of the controlassembly 38, as indicated by the arrow 192. Accordingly, the cardiacharness 42 is released from the plurality of push rods 40, preferably ina manner similar to that described above with reference to FIGS. 11a-c.

[0129] With reference to FIG. 22, once the cardiac harness 42 has beenreleased from the plurality of push rods 40, the generally-elasticharness preferably contracts onto the heart. The control assembly 38 isthen retracted relative to the shaft 34 to retract the plurality of pushrods 40 from the cardiac harness 42, which remains on the heart 172. Asnoted above, preferably, the push rods 40 are configured such thatretraction of the push rods 40 does not tend to pull the cardiac harness42 from its desired position on the heart 172. Specifically, in theillustrated embodiment, the outwardly canted tips 154 of the pluralityof push rods 40 help prevent the push rods 40 from exerting a pullingforce on the cardiac harness 42.

[0130] With reference to FIG. 23, once the plurality of push rods havebeen fully retracted from the cardiac harness 42 and the heart 172, theone-way valve 59 within the connector 58 may be opened to release thevacuum condition with the tube 54. As a result, the delivery device 30may be removed from the heart 172, as indicated by the arrow 194 in FIG.23, as the suction cup member 52 is no longer grasping the heart 172.Thus, the delivery device 30 is retracted from the heart, leaving thecardiac harness 42 in place.

[0131] As discussed above, the delivery device 30 holds the cardiacharness 42 at several spaced apart locations. As such, the device exertsa distributed hold on the harness 42. Due to the distributed hold, thedevice can be used to advance the harness 42 as discussed above and alsocan be used to adjust the positioning and orientation of the harnesswithout substantially deforming the harness 42. For example, if theharness is advanced distally farther than desired, the control assembly38 can be pulled proximally somewhat in order to fine tune the positionof the harness relative to the heart. Due to the distributed holdbetween the device 30 and the harness 42, the harness will moveproximally as desired without substantial deformation, such as foldingover itself or the like. Furthermore, in another embodiment, theposition of the harness can be adjusted not only distally and proximallybut also rotationally without substantially deforming the harness.

[0132] Although the delivery device 30 is especially well suited for usein a minimally invasive delivery procedure, the device 30 may also beused for open chest procedures, wherein the sternum of the patient issplit to provide access to the heart 172. Accordingly, the deliverydevice 30 may be used with or without the delivery arrangementillustrated in FIGS. 13-18. In addition, although the device 30described herein utilizes a plurality of push rods 40, other suitablestructures may also be used as support structures to support the cardiacharness 40, when being advanced over the heart. For example, anexpandable sleeve can serve as a support structure. Furthermore, it isto be understood that a cardiac harness 42 may be releasably supportedin an expanded, or substantially expanded, configuration to a variety ofsupport structures by the releasable stitch described herein, or by asimilar releasable stitch arrangement.

[0133] With reference next to FIGS. 24-27, an embodiment of a cardiacharness loading device 200 is illustrated. The loading device 200 isconfigured to cooperate with the delivery device 30 to support theplurality of push rods 40 in an outwardly splayed orientation so thatthe cardiac harness 42 may be secured to the push rods 40. The loadingdevice 200 may also be useful to assist in urging the cardiac harness 42from an expanded or at rest configuration to a compacted configuration,so as to be insertable into the housing 36 of the delivery device 30.

[0134] The illustrated loading device 200 is generally funnel shaped,having a cone-shaped upper portion 202 extending upwardly from agenerally cylindrical lower portion 204. The lower portion 204 includesa pocket 206, which is configured to receive a distal end of thedelivery device 30, and more specifically the suction cup member 52. Ina preferred embodiment, however, the suction cup is removed while theharness is loaded, and is attached after the loading of the harness iscomplete.

[0135] Preferably, the loading device 200 is a thin-walled hollow memberand, in the illustrated embodiment, is constructed from a pair of mirrorimage halves 200 a, 200 b (FIG. 26) coupled to one another by a pair ofpinned flanges 205 a, 205 b. That is, a pin 207 extends through a cavityextending through each half 200 a, 200 b within each flange 205 a, 205b, thereby securing the halves 200 a, 200 b to one another. It is to beunderstood that the halves 200 a, 200 b may be coupled in any manner. Inan additional embodiment, the loading device comprises a single member.

[0136] With particular reference to FIGS. 25 and 26, a plurality ofchannels 208 preferably extend upwardly from the pocket 206 andterminate at the open, upper end of the cone-shaped upper portion 202.Desirably, each of the channels 208 is shaped to receive one of theplurality of push rods 40 and, preferably, are shaped generallycomplementary to the shape of the push rods 40. Therefore, desirably,the number of channels 208 provided is equal to the number of push rods40 present in the delivery device 30. Thus, each channel 208 isconfigured to receive and position one of the plurality of push rods 40in an appropriate splayed position such that the cardiac harness 42 maybe releasably secured thereto.

[0137] A lower portion 208 a of each channel 208 preferably issubstantially parallel to a center axis of the delivery device 30 whenthe distal end of the device 30 is positioned within the pocket 206 ofthe loading device 200. An upper portion 208 b of the channel 208,corresponding with the upper portion 202 of the loading device 200,preferably is splayed in an outward direction relative to the lowerportion 208 a. Thus, when received within the upper portion 208 b of thechannels 208, the push rods 40 preferably are oriented in a splayedconfiguration, similar to the position assumed when the push rods 40 arepositioned over a heart.

[0138] Desirably, the loading device 200 includes a plurality of cut outportions 210 corresponding with an elongate portion of each upperportion 208 b of the channels 208. Preferably, the cut out portions 210are disposed on an outer surface of the loading device 200 and expose anelongate portion of a push rod 40 disposed in the upper portion 208 b ofthe channel 208 (see FIG. 27). In addition, preferably the entirechannel 208 is open toward an inner surface of the loading device 200.Desirably, the cut out portions 210 correspond with a portion of thecorresponding push rods 40 in which the through holes 62, 64 a-i (FIG.5) are provided. As such, the loading device 200 secures the push rods40 in a splayed orientation with the through holes 62, 64 a-i exposed sothat the cardiac harness 42 may be releasably secured to each of thepush rods 40 by a releasable stitch.

[0139]FIG. 27 illustrates a cardiac harness 42 disposed in the loadingdevice 200 along with and adjacent the push rods 40. In the illustratedarrangement, the harness 42 is ready to be secured to the push rods 40.

[0140] With reference next to FIGS. 28a-c, a preferred method forcreating the releasable stitch from a line 60 a is illustrated. Withreference to FIG. 28a, the cardiac harness 42 preferably is positionedrelative to the push rod 40 such that an upper most row 66 a of theharness 42 is positioned between through holes 62 and 64 a of the pushrod 40, or the two uppermost through holes. The line 60 a is passedalong the inward facing surface 40 b of the push rod 40 in an upwarddirection positioning the cardiac harness 42 between the line 60 a andthe surface 40 b of the push rod 40. An upper end of the line 60 a ispassed through the through hole 62 and, preferably, formed into a slipknot 80, which forms the initial loop 82 a of the releasable stitch.

[0141] With reference to FIG. 28c, preferably an instrument, such as ahook 220 is passed through the loop 82 a and grasps a portion of theline 60 a below the upper row 66 a of the cardiac harness 42. The line60 a is pulled through the through hole 64 a and through the initialloop 82 a, to secure the upper row 66 a of the cardiac harness 42 to thepush rod 40. With reference to 28 c, the line 60 a is pulled furtherthrough the loop 82 a to create the second loop 82 b. This process isrepeated until each of the rows 66 a-h are secured to each of theplurality of push rods 40. With reference again to FIG. 5, the finalloop, or retention loop 86 a, preferably is retained by the rod 68 a ofthe release member 136, as previously described. In addition, preferablythe end 100 a of the line 60 a is tied off on the release member 136, asalso described above.

[0142] With reference again to FIG. 27, once the cardiac harness 42 isreleasably secured to each of the push rods 40, the control assembly 38may be retracted relative to the shaft 34 to retract the push rods 40and, thus, retract the cardiac harness 42 into its compactedconfiguration within the housing 36 of the delivery device 30 (asillustrated in FIG. 2). As described above, the funnel shape of theupper portion 202 and the cylindrical shape of the lower portion 204 ofthe loading device 200 assist in urging the cardiac harness 42 from itsexpanded configuration into its compacted configuration.

[0143] With reference next to FIGS. 29-32, another embodiment of acontrol assembly 238 and associated push rods 240 is illustrated. In theillustrated embodiment, the control assembly 238 comprises a bodyportion 242 and a handle portion 244 which are configured to slideaxially over the shaft 34.

[0144] With particular reference to FIG. 29, the body portion 242includes a first and a second friction brake assembly 246, 248.Preferably, each friction brake assembly 246, 248 is constructed in amanner similar to the assembly 102 described above in connection withFIGS. 6-9. However, the pivoting direction and orientation of the brakeelement 104 portion in the first brake assembly 246 is reversed relativeto such orientation in the second brake assembly 248. As such, axialmovement of the control assembly 238 over the shaft 34 can beselectively inhibited in either a distal or proximal direction byselectively engaging the first or second brake assembly 246, 248.

[0145] With particular reference to FIGS. 30-32, the elongate push rod240 includes a plurality of through holes, or openings 262, 264extending therethrough. The push rod 240 is configured to accept areleasable stitch such as that discussed above in connection with FIG. 5and as will be discussed below in connection with FIG. 33. Preferably,the push rod is constructed of a radiopaque material.

[0146] With more particular reference to FIG. 31, a distal tip 249 ofthe push rod 240 comprises a generally barrell-shaped atraumatic tipportion 260. It is to be understood, however, that the atraumatic tip260 can be shaped in several different ways in order to minimize thelikelihood that the tip will puncture, scratch or otherwise traumatizetissue. For example, the tip can be folded over, be generally teardropshaped, or be generally cylindrical.

[0147] With particular reference next to FIGS. 30 and 32, a proximalregion 266 of the push rod 240 comprises a plurality of ribs 270attached to a spine 271 of the rod 240. The ribs 270 extend outwardlyand function to increase the rigidity of the rod in the proximal region266. An elongate passage 272 is formed between the ribs, and defines aline path 272 configured to accommodate a line 60 a extendingtherethrough. The ribs 270 increase the rigidity of the push rod 240 inthe proximal region 266. As such, the push rod 240 is more flexible in adistal region 273 than in the proximal region 266. It is to beunderstood that, in other embodiments, further structural or materialstrategies can be used to further vary the flexibility of push rodsalong their length.

[0148] In the illustrated embodiment, the ribs 270 do not extend all theway to a proximal end 274 of the push rod 240. At or near the proximalend, a pair of cutouts 276 are formed at opposite sides of the push rod.

[0149] With reference again to FIGS. 29 and 30, a series of passages 250are formed in the body 242 of the control assembly 238. Each passage 250comprises a rod portion 252 and a line portion 254. The rod portions 256are configured so that the proximal end 274 of each push rod 240 fitsinto the rod portion 252 of the passage 250. The line portions 254generally align with the line path 272 between the ribs 210 of theinstalled push rod 240, and thus provides a passage for the line 60 a totravel into the control assembly 238. A pair of pin passages 256 areformed in the control assembly corresponding to each rod passage. Thepin passages 256 are configured to generally align with the cutouts 276at the proximal end 274 of each push rod 240. Locking pins 258 (see FIG.34) are inserted into the pin passages 256 and through the cutouts 276in order to support the push rod 240 in place in the control assembly238.

[0150] With reference next to FIG. 33, another arrangement forreleasably holding a harness 42 onto a push rod 40 is illustrated. Thisembodiment is quite similar to the embodiment discussed above inconnection with FIG. 5, in that several interconnected loops 82 a-h arearranged to create securing portions 84 a-h of a line 60 a in order toengage and secure rows 66 a-h of the cardiac harness 42 to secure theharness onto the push rod 40. In the illustrated embodiment, aproximal-most loop, referred to as a free loop 280, extends along anouter surface 40 a of the push rod 40 proximal of a proximal-mostthroughhole 64 i. A retaining loop 282 portion of the line 60 a extendsfrom the inner surface 40 b of the push rod 40 through the hole 64 i andloops about the free loop 280. From the retaining loop 282, an endportion 100 a of the line 60 a extends to the release member 68. Tensionin the line 60 a holds the free loop 280 in place, and a friction forceresists drawing of the free loop 280 through the retaining loop 282 inorder to release the releasable stitch. Further, in this arrangement,only a single line 60 a is drawn down through the line path 272 and intothe control assembly 38 or 238.

[0151] With continued reference to FIG. 33, once the harness 42 is inplace upon a patient's heart, the release member 68 is actuated in orderto pull the line 60 a. As such, the retaining loop 282 engages and pullson the free loop 280. This interaction between the loops 280, 282creates frictional resistance; however, upon continued pulling by theclinician, the frictional resistance is overcome and the retaining loop282 is disengaged from the free loop 280, at which point the releasablestitch disengages in the same manner as discussed above with referenceto FIGS. 11a-c.

[0152] In the illustrated embodiment, the push rod 40 resembles the pushrod 40 presented in FIG. 5. It is to be understood that thejust-discussed embodiment can also be employed in connection with a pushrod 240 as depicted in FIGS. 30-32, or with any suitable push rod.

[0153] With reference next to FIG. 34, an interior view of the controlassembly 238 of FIG. 29 is shown. In this embodiment, the line andstitching arrangement of FIG. 33 is employed. As such, only a singleline 100 a extends into the control assembly 238 from each push rod 240,and no loop extends into the control assembly 238. An end of each line100 a-f is tied onto the release member 268. As shown in FIG. 34,(channels 284 a,b, 286 a,b extend between each control assembly passageline portion to the release member 268 in order to accommodate each line100 a-f. The lines 100 a-f associated with each push rod 240 extendthrough the associated channels 284 a,b, 286 a,b to the release member268. As such, when the release member 268 is pulled outwardly, the lines100 a-f are pulled so as to release the loops holding the harness 42onto the push rod.

[0154] In the embodiments disclosed herein, the illustrated cardiacharness 42 is formed of several rows of elastic elements. Theillustrated harness comprises undulating wire arranged in severaladjacent rings, each of which comprises an elastic row. As illustrated,the harness 42 is releasably attached to the push rods by a stitch beingwound around some or all of the rows. Of course, it is to be understoodthat aspects of the present invention can be employed with harnesseshaving different structure than the illustrated harness, which isincluded for example only. For example, any harness having one or moreopenings that could accommodate the releasable stitch could be used suchas, for example, a harness formed of a woven or non-woven fibrousmaterial and/or a harness formed of a mesh, honeycomb or other type ofmaterial.

[0155] Although the present invention has been described in the contextof a preferred embodiment, it is not intended to limit the invention tothe embodiment described. Accordingly, modifications may be made to thedisclosed embodiment without departing from the spirit and scope of theinvention. For example, any of a variety of suitable releasablestitches, or other releasing mechanisms, may be used. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments discussed herein may bemade. Accordingly, various features and aspects of the disclosedembodiments can be combined with or substituted for one another in orderto form varying modes of the invention. In addition, although theillustrated device 30 is well suited for delivering a cardiac harnessthrough a minimally invasive procedure, the illustrated device 30, oralternative arrangements thereof, may also be used in an open chestprocedure. Accordingly, the invention is intended to be defined only bythe claims that follow.

1-25. (canceled)
 26. A method for mounting a cardiac harness over theheart, comprising: providing a cardiac harness sized smaller than aheart; compressing the cardiac harness and loading the harness on asupport member; elastically stretching the harness to fit over a portionof the heart; and contracting the harness onto the portion of the heart.27. The method of claim 26, wherein the support member comprisesflexible push rods releaseably attached to the cardiac harness, theflexible push rods splaying outwardly to follow the contour of the heartas the push rods are advanced out of the support member.
 28. The methodof claim 27, wherein the cardiac harness is elastically biased inwardlyto closely follow the contour of the heart as the push rods advance thecardiac harness over the portion of the heart.
 29. The method of claim28, wherein the cardiac harness pulls the flexible push rods inwardlytoward the heart as the harness is advanced over the portion of theheart.
 30. The method of claim 29, wherein the cardiac harness is formedfrom a NiTi alloy.
 31. The method of claim 26, wherein the cardiacharness and support member are inserted through a minimally invasiveaccess site.
 32. The method of claim 31, wherein the cardiac harness isvisualized by fluoroscopy.
 33. The method of claim 32, wherein thecardiac harness is mounted on a beating heart.
 34. The method of claim33, wherein prior to mounting the cardiac harness on the heart,releaseably grasping and manipulating the heart to better position thecardiac harness relative to the heart.
 35. The method of claim 34,wherein a suction device is used to releaseably grasp the heart.
 36. Amethod for mounting a cardiac harness over the heart, comprising:providing a cardiac harness sized smaller than a heart when the cardiacharness is in a relaxed configuration; compressing the cardiac harnessand loading the harness on a support member; elastically stretching thecardiac harness to fit over a portion of the heart; releasing thecardiac harness from the support member; and the cardiac harnessautomatically contracting onto the portion of the heart.
 37. The methodof claim 36, wherein the support member comprises flexible push rodsreleaseably attached to the cardiac harness, the flexible push rodssplaying outwardly to follow the contour of the heart as the push rodsare advanced out of the support member.
 38. The method of claim 37,wherein the cardiac harness is elastically biased inwardly to closelyfollow the contour of the heart as the push rods advance the cardiacharness over the portion of the heart.
 39. The method of claim 38,wherein the cardiac harness pulls the flexible push rods inwardly towardthe heart as the harness is advanced over the portion of the heart. 40.The method of claim 36, wherein the cardiac harness and support memberare inserted through a minimally invasive access site.
 41. The method ofclaim 40, wherein the cardiac harness is visualized by fluoroscopy. 42.The method of claim 41, wherein the cardiac harness is mounted on abeating heart.
 43. The method of claim 42, wherein prior to mounting thecardiac harness on the heart, releaseably grasping and manipulating theheart to better position the cardiac harness relative to the heart. 44.The method of claim 43, wherein a suction device is used to releasablygrasp the heart.
 45. A method for mounting a cardiac harness on theheart, comprising: providing a cardiac harness sized smaller than aheart; compressing the cardiac harness and loading the harness on asupport member; elastically stretching the cardiac harness over theheart as the support member advances the harness from the smallerdiameter apex portion of the heart to the relatively larger base portionof the heart; and the harness being preloaded to provide a compressiveforce on the heart as the harness is being mounted on the heart.
 46. Themethod of claim 45, wherein the cardiac harness is formed from NiTialloy to provide the compressive force.
 47. The method of claim 45,wherein the cardiac harness and support member are inserted through aminimally invasive access site.
 48. The method of claim 47, wherein thecardiac harness is visualized by fluoroscopy.
 49. The method of claim48, wherein the cardiac harness is mounted on a beating heart.
 50. Themethod of claim 49, wherein prior to mounting the cardiac harness on theheart, releaseably grasping and manipulating the heart to betterposition the cardiac harness relative to the heart.
 51. The method ofclaim 50, wherein a suction device is used to releaseably grasp theheart.